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Medi-First

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Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 3, 2025
Drug Information (PDF)
Prescribing information, PDF file
Active ingredients
  • Lidocaine Hydrochloride 5 mg/1 g
  • Benzalkonium Chloride 1.3 mg/1 g
Other brand names
Drug classes
Amide Local Anesthetic, Antiarrhythmic
Dosage form
Cream
Route
Topical
Prescription status
OTC (over the counter)
CSA schedule
Not a scheduled drug
Pregnancy
See Pregnancy Use Section
Lactation
See Lactation Use Section
Marketed in the U.S.
Since 2025
Label revision date
September 3, 2025
Manufacturer
Orazen Inc
Registration number
M017
NDC root
71927-019
Drug Information (PDF)
Prescribing information, PDF file
Packaging Info
Packaging & NDC Codes

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

If you are a consumer or patient please visit this version.

Drug Overview

This medication is designed to provide temporary relief from pain associated with minor burns. In addition to alleviating pain, it also helps protect the affected area from harmful bacteria, promoting a safer healing environment. If you’re dealing with a minor burn, this drug can be a supportive option to help manage your discomfort while protecting your skin.

Uses

If you're dealing with minor burns, this product can provide temporary relief from the pain associated with those injuries. In addition to soothing discomfort, it also helps protect your skin from harmful bacteria, which can prevent infections and promote healing. This makes it a useful option for managing minor burn injuries effectively.

Dosage and Administration

To use this medication effectively, start by cleaning the affected area thoroughly. For adults and children aged 2 years and older, apply a small amount of the medication to the area. You can do this up to 3 to 4 times each day, ensuring you don’t use more than the recommended amount.

If you have a child under 2 years old, it’s important not to use this medication without first consulting a doctor. Always follow these guidelines to ensure safe and effective use.

What to Avoid

It's important to use this product safely to avoid potential issues. You should never apply it to your eyes or use it in large amounts. Additionally, avoid using it on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you find that you need to use it for more than one week, please consult your doctor for guidance. Following these instructions will help ensure your safety and the effectiveness of the treatment.

Side Effects

This product is intended for external use only. If your condition worsens, or if your symptoms last longer than 7 days, or if they improve and then return within a few days, you should stop using the product and consult a doctor. It's important to monitor your symptoms closely to ensure your health and safety.

Warnings and Precautions

This product is for external use only, so please avoid applying it to your eyes or using it in large amounts. It should not be used on raw or blistered skin, deep puncture wounds, animal bites, or serious burns. If you need to use it for more than a week, consult your doctor first.

Keep this product out of reach of children. If it is accidentally ingested, seek medical help or contact a Poison Control Center immediately.

You should stop using the product and call your doctor if your condition worsens, if symptoms last longer than 7 days, or if symptoms improve and then return within a few days.

Overdose

It appears that there is no specific information available regarding overdosage for this medication. However, it's always important to be aware of the signs of an overdose, which can include symptoms like extreme drowsiness, confusion, or difficulty breathing. If you suspect that you or someone else may have taken too much of a medication, it’s crucial to seek immediate medical help.

In case of an overdose, contact your local emergency services or go to the nearest hospital. Having the medication packaging or information on hand can help healthcare professionals provide the best care. Always remember that when it comes to medications, it's better to be safe and get help if you have any concerns.

Pregnancy Use

The safety of this product during pregnancy has not been established, which means that it may not be safe for you or your developing baby. It is important to note that using this product while pregnant is contraindicated, as there are potential risks to the fetus.

If you are pregnant or planning to become pregnant, it is crucial to consult your healthcare provider before using this product. They can provide guidance and help you understand any risks involved. Your health and the health of your baby are the top priority, so always seek professional advice when it comes to medication during pregnancy.

Lactation Use

If you are breastfeeding, you can feel reassured that there are no specific warnings or recommendations regarding the use of this product while nursing. Additionally, there is no information available about whether this product is excreted in breast milk or any potential risks it may pose to your infant. Always consult with your healthcare provider if you have any concerns or questions about medications while breastfeeding.

Pediatric Use

If you have a child under 2 years old, it's important not to use this medication without first consulting a doctor. For children aged 2 years and older, you can apply a small amount of the medication to the affected area, but make sure to clean the area first. You should only apply it 3 to 4 times a day. Always follow these guidelines to ensure your child's safety and well-being.

Geriatric Use

When it comes to using this medication in older adults, there is no specific information available about dosage adjustments, safety concerns, or special precautions. This means that healthcare providers may not have tailored guidelines for elderly patients.

If you or a loved one is an older adult considering this medication, it’s important to discuss any potential risks and benefits with your healthcare provider. They can help determine the best approach based on individual health needs and conditions. Always prioritize open communication with your doctor to ensure safe and effective treatment.

Renal Impairment

It appears that there is no specific information regarding dosage adjustments, monitoring, or safety considerations for patients with kidney problems in the provided drug insert. This means that if you have renal impairment (kidney issues), you should consult your healthcare provider for personalized advice and recommendations. They can help determine the best course of action based on your individual health needs and any medications you may be taking. Always prioritize open communication with your doctor about your kidney health when discussing treatment options.

Hepatic Impairment

If you have liver problems, it's important to know that the drug insert does not provide specific information about dosage adjustments, special monitoring, or precautions for your condition. This means that there are no tailored guidelines for how this medication may affect you if you have hepatic impairment (liver issues).

Always consult your healthcare provider for personalized advice and to discuss any concerns regarding your liver health and how it may relate to your treatment. They can help ensure that your medication is safe and effective for you.

Drug Interactions

It's important to have open conversations with your healthcare provider about any medications or tests you may be taking. While there are no specific drug interactions or laboratory test interactions noted for this medication, your healthcare provider can help ensure that everything you are taking works well together and is safe for you.

Always discuss your full list of medications, including over-the-counter drugs and supplements, as well as any lab tests you may need. This way, you can avoid any potential issues and receive the best care possible.

Storage and Handling

To ensure the safety and effectiveness of your product, store it at room temperature and avoid freezing. It's important to keep the product in its tamper-evident sealed packets until you're ready to use it. If you notice any opened or torn packets, do not use them, as this could compromise the product's integrity and safety. Following these guidelines will help you handle the product properly and maintain its quality.

Additional Information

No further information is available.

FAQ

What is the drug indicated for?

The drug is indicated for the temporary relief of pain associated with minor burns and helps protect against harmful bacteria.

How should adults and children over 2 years use this drug?

Clean the affected area and apply a small amount not more than 3 to 4 times daily.

Can children under 2 years use this drug?

No, do not use this drug in children under 2 years; consult a doctor instead.

What should I do if my condition worsens or symptoms persist?

Stop use and ask a doctor if the condition worsens or if symptoms persist for more than 7 days.

Are there any contraindications for using this drug?

Yes, do not use this drug in the eyes, in large quantities, over raw or blistered areas, or on deep puncture wounds, animal bites, or serious burns.

Is this drug safe to use during pregnancy?

The safety of this product during pregnancy has not been established, and it is contraindicated due to potential risks to the fetus.

What precautions should I take if I am pregnant or planning to become pregnant?

Consult a healthcare provider before use if you are pregnant or planning to become pregnant.

What should I do if I accidentally ingest this drug?

If ingested, get medical help or contact a Poison Control Center right away.

How should I store this drug?

Store at room temperature and do not freeze. Ensure packets are tamper evident and do not use any opened or torn packets.

Packaging Info

Below are the non-prescription pack sizes of Medi-First (benzalkonium chloride, lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First.
Details

Drug Information (PDF)

This file contains official product information for Medi-First, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Description

No description information is available for the specified drug.

Uses and Indications

This drug is indicated for the temporary relief of pain associated with minor burns. Additionally, it helps protect against harmful bacteria, contributing to the overall management of minor burn injuries.

There are no teratogenic or nonteratogenic effects mentioned in the available data.

Dosage and Administration

For adults and children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product should be applied to the affected area, not exceeding 3 to 4 times daily.

In children under 2 years of age, the product is not recommended for use. Consultation with a healthcare professional is advised before administration in this age group.

Contraindications

Use is contraindicated in the following situations:

  • Application in the eyes is prohibited due to potential for irritation and damage.

  • Avoid use in large quantities to prevent adverse effects.

  • Do not apply over raw or blistered areas, deep puncture wounds, animal bites, or serious burns, as these conditions may exacerbate irritation or lead to complications.

  • Prolonged use beyond one week is contraindicated unless directed by a healthcare professional to mitigate risks of adverse reactions.

Warnings and Precautions

For external use only. It is imperative that this product is kept out of reach of children. In the event of ingestion, immediate medical assistance should be sought, or contact a Poison Control Center without delay.

This product should not be used in the eyes, in large quantities, or over raw or blistered areas. It is contraindicated for application on deep puncture wounds, animal bites, or serious burns. Additionally, use should not exceed one week unless specifically directed by a healthcare professional.

Healthcare providers should advise patients to discontinue use and consult a doctor if the condition worsens, if symptoms persist for more than seven days, or if symptoms resolve and then recur within a few days. Regular monitoring of the patient's condition is recommended to ensure safety and efficacy during treatment.

Side Effects

Patients should be aware that the product is intended for external use only. In clinical practice, it is important to monitor for any worsening of the condition or if symptoms persist beyond 7 days. Should these situations arise, patients are advised to discontinue use and consult a healthcare professional. Additionally, if symptoms resolve and then recur within a few days, it is recommended that patients seek medical advice.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Medi-First (benzalkonium chloride, lidocaine). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Packaging configurations for Medi-First.
Details

Pediatric Use

Pediatric patients under 2 years of age should not use this product without consulting a healthcare professional. For children aged 2 years and older, the affected area should be cleaned prior to application. A small amount of the product may be applied up to 3 to 4 times daily.

Geriatric Use

There is no specific information available regarding the use of this medication in geriatric patients, including dosage adjustments, safety concerns, or special precautions. Healthcare providers should exercise caution when prescribing this medication to elderly patients, as individual responses may vary. It is advisable to monitor these patients closely for any adverse effects or changes in efficacy.

Pregnancy

The safety of this product during pregnancy has not been established. Use is contraindicated in pregnancy due to potential risks to the fetus. Pregnant patients or those planning to become pregnant should consult a healthcare provider before use to discuss potential risks and benefits.

Lactation

There are no specific warnings or recommendations regarding the use of this product in nursing mothers. Additionally, there is no information available about the potential for excretion in breast milk or any associated risks to breastfed infants.

Renal Impairment

There is no information available regarding renal impairment, including dosage adjustments, special monitoring, or safety considerations for patients with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of specific guidance when prescribing to patients with renal impairment.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary depending on the substance involved and the individual patient’s characteristics. Symptoms of overdose can range from mild to severe and may include altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate assessment of the patient’s condition is crucial. Recommended actions include:

  1. Assessment: Conduct a thorough evaluation of the patient, including vital signs and a detailed history of substance use.

  2. Supportive Care: Initiate supportive measures as necessary, which may include airway management, oxygen supplementation, and intravenous fluids.

  3. Toxicology Consultation: Consider consulting a poison control center or a toxicologist for guidance on specific management strategies tailored to the substance involved.

  4. Monitoring: Continuous monitoring of the patient’s vital signs and clinical status is essential to detect any deterioration promptly.

It is imperative for healthcare professionals to familiarize themselves with the specific antidotes or treatment protocols relevant to the substance in question, as these may significantly influence patient outcomes in cases of overdose.

Nonclinical Toxicology

No teratogenic or non-teratogenic effects have been reported in the available nonclinical studies. Additionally, there is no information regarding animal pharmacology and toxicology. The absence of data limits the assessment of potential risks associated with the compound in these areas.

Postmarketing Experience

No postmarketing experience details are available in the insert.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. It is important to emphasize the potential risks associated with ingestion. In the event that the medication is ingested, patients should be instructed to seek medical help immediately or contact a Poison Control Center for guidance. This information is crucial for ensuring patient safety and minimizing the risk of adverse effects.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure safety and integrity. It is essential to store the packets at room temperature and to avoid freezing. Healthcare professionals should not use any packets that are opened or torn, as this may compromise the product's quality and efficacy.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Medi-First, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)

Data Generation & Sources

This page was automatically generated and is maintained by the AllDrugs AI Data-Science Team. It was built from the FDA Structured Product Label (DailyMed) for Medi-First, retrieved by a validated AI data-extraction workflow.

All FDA-listed dosage forms and strengths are shown in the Packaging & NDC Codes section above. Regulatory status appears in the Summary Information panel above and was verified in the FDA National Drug Code directory and the NSDE NDC Directory daily file.

Note: an automated daemon monitors NSDE checksums; when the record for this NDC changes, the new file is pulled instantly and this page is refreshed.

No human clinician has reviewed this version.

Learn more in our Editorial Policy

Last AI update:

Primary FDA sources:

Orange Book data shown on this page are limited to Regulatory Status (Rx), Established Pharmacologic Class (EPC), and Mechanism of Action (MoA).

Regulatory data notice: Information on this page is reproduced verbatim from FDA public databases (NSDE, Orange Book, Purple Book, DailyMed SPL). NDA/ANDA drugs are FDA-approved, BLA biologics are FDA-licensed. Inclusion alone does not guarantee current market availability or imply FDA endorsement.

Medical disclaimer: This AI-generated content is provided for educational purposes only and does not constitute medical advice. Always consult a licensed healthcare professional for diagnosis or treatment decisions.